Baxter—Polyflux Revaclear Max Dialyzers: Particulate Matter May Be Present in Blood Side of Dialyzer
October 26, 2016 | Strategic Insights for Health System
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at email@example.com.
In an October 12, 2016, Urgent Product Recall letter submitted by an ECRI Institute member hospital, Baxter states that particulate matter may be present in the blood side of the above dialyzers. Baxter also states that this problem was identified as a result of one customer report regarding the presence of black fibers and dust in the dialyzer. Baxter further states that the user may not visually detect the presence of foreign material in the blood side of the dialyzer and that, when the dialyzer is used, the particles may become dislodged by flow, potentially reaching the vascular system of the patient, which could lead to serious adverse health consequences. Baxter states that it has received no...